Quality Assurance Specialist

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Developing and implementing quality control tests, inspecting products at various stages and writing reports documenting production issues.
Lead internal and external nonconformities, closing them on a timely manner.
Support the Quality Manager during second-party audits
Own Suppliers/Subcontractors qualification and monitoring
Promote the continuous improvement by Handling Corrective and Preventive Actions
Support periodic data collection for Management Review KPIs.
Guarantee a constant alignment with the Quality Assurance Manager by providing suitable data
Qualifications:
Proficient in English Language.
Technical writing of GMP manufacturing environment.
Quality standards as ISO 13485, ISO 9001 e CFR 21.
Medical Device and In Vitro Diagnostics Regulations.
Problem Solving.
Data Analysis in a clear and efficient way.
CAPA certification, is a plus
Full time regular position
Administrative shift
Northwest area in Puerto Rico
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job Types: Full-time, Permanent
Benefits:
401(k)
Health insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Required)
Experience:
Manufacturing: 2 years (Preferred)
Quality Assurance: 2 years (Preferred)
Shift availability:
Day Shift (Preferred)
Work Location: In person